{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T16:48:57Z","timestamp":1792514937798,"version":"4.5.0"},"reference-count":35,"publisher":"American Diabetes Association","issue":"12","license":[{"start":{"date-parts":[[2016,6,1]],"date-time":"2016-06-01T00:00:00Z","timestamp":1464739200000},"content-version":"vor","delay-in-days":299,"URL":"http:\/\/www.diabetesjournals.org\/site\/license"}],"funder":[{"DOI":"10.13039\/100014598","name":"MannKind Corporation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100014598","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2015,12,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>To investigate the efficacy and safety of prandial Technosphere inhaled insulin (TI), an inhaled insulin with a distinct time action profile, in insulin-na\u00efve type 2 diabetes (T2D) inadequately controlled on oral antidiabetes agents (OADs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>Subjects with T2D with HbA1c levels \u22657.5% (58.5 mmol\/mol) and \u226410.0% (86.0 mmol\/mol) on metformin alone or two or more OADs were randomized to add-on prandial TI (n = 177) or prandial Technosphere inhaled placebo (TP) (n = 176) to their OAD regimen in this double-blind, placebo-controlled trial. Primary end point was change in HbA1c at 24 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>TI significantly reduced HbA1c by \u22120.8% (\u22129.0 mmol\/mol) from a baseline of 8.3% (66.8 mmol\/mol) compared with TP \u22120.4% (\u22124.6 mmol\/mol) (treatment difference \u22120.4% [95% CI \u22120.57, \u22120.23]; P &amp;lt; 0.0001). More TI-treated subjects achieved an HbA1c \u22647.0% (53.0 mmol\/mol) (38% vs. 19%; P = 0.0005). Mean fasting plasma glucose was similarly reduced in both groups. Postprandial hyperglycemia, based on 7-point glucose profiles, was effectively controlled by TI. Mean weight change was 0.5 kg for TI and \u22121.1 kg for the TP group (P &amp;lt; 0.0001). Mild, transient dry cough was the most common adverse event, occurring similarly in both groups (TI, 23.7%; TP, 19.9%) and led to discontinuation in only 1.1% of TI-treated and 3.4% of TP-treated subjects. There was a small decline in forced expiratory volume in 1 s in both groups, with a slightly larger decline in the group receiving TI (TI, \u22120.13 L; TP, \u22120.04 L). The difference resolved after treatment discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Prandial TI added to one or more OADs in inadequately controlled T2D is an effective treatment option. Mild, transient dry cough was the most common adverse event.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc15-0629","type":"journal-article","created":{"date-parts":[[2015,8,8]],"date-time":"2015-08-08T02:29:40Z","timestamp":1439000980000},"page":"2274-2281","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":37,"title":["Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Na\u00efve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents"],"prefix":"10.2337","volume":"38","author":[{"given":"Julio","family":"Rosenstock","sequence":"first","affiliation":[{"name":"Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise","family":"Franco","sequence":"additional","affiliation":[{"name":"CPCLIN Clinical Research Center, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vadym","family":"Korpachev","sequence":"additional","affiliation":[{"name":"V.P. 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